FDA 510(k) Application Details - K112490

Device Classification Name	Human Metapneumovirus (Hmpv) Rna Assay System   More FDA Info for this Device
510(K) Number	K112490
Device Name	Human Metapneumovirus (Hmpv) Rna Assay System
Applicant	QUIDEL CORP. 10165 MCKELLAR CT. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Ronald H Lollar Other 510(k) Applications for this Contact
Regulation Number	866.3980   More FDA Info for this Regulation Number
Classification Product Code	OEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2011
Decision Date	12/15/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review